Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) on First Line Platinum
|ClinicalTrials.gov Identifier: NCT01355497|
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : March 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Muscle Wasting Non-Small Cell Lung Cancer||Drug: GTx-024 Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer on First Line Platinum Plus a Non-Taxane Chemotherapy|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||June 2014|
subjects will be randomized to receive GTx-024 for the duration of the trail
subjects will be randomized to receive GTx-024 for the duration of the trial.
Placebo Comparator: placebo
subjects will be randomized to receive placebo for the duration of the trial
subject will receive placebo for the duration of the trial
- Improved Physical function [ Time Frame: Day 84 ]Physical function will be assessed by stair climb power at Day 84.
- Increased lean body mass [ Time Frame: Day 84 ]At Day 84 a repeat Whole Body Composition Dexa Scan will be done and compared to the baseline Dexa.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355497
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